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Today, FDA's advisers will consider the first covid vaccine for children and the White House says it doesn't have “unlimited rights” to Moderna's recipe. But first:

On the chopping block: new Medicaid and Medicare benefits

Medicaid expansion is getting the Manchin treatment. 

Powerful lawmakers have pushed to extend the safety net program to 2.2 million people in a dozen states that have refused Obamacare’s expansion. But yesterday, Sen. Joe Manchin (D-W.Va.) publicly aired concerns with a fix where the federal government foots the whole bill. He argued it would be unfair to states like his that already chose to expand Medicaid under the previous terms with less government contribution, our colleague Tony Romm reports.

Now, Manchin’s fellow Democrats are reaching out in a last-minute effort to try and get him on board. This includes two key champions of closing the Medicaid coverage gap: House Majority Whip Jim Clyburn (D-S.C.) and Sen. Raphael Warnock (D-Ga.).

  • “I’m gonna do everything I can to make sure that Medicaid expansion stays in this bill,” said Warnock, who's running for re-election next year and has made it a priority to expand the safety net program in his state. An aide to Clyburn confirmed the congressman had also reached out to Manchin.

The episode is emblematic of the fragile state of negotiations over Biden’s social spending bill. Congressional leaders are racing to forge a compromise in the next few days that can get nearly all members of their slim Democratic majority on board.

Burgess Everett, Politico

The party’s sweeping plans to bolster Medicare and Medicaid benefits may be whittled or cut amid an assault from industry groups and opposition from centrists, Dan Diamond, Amy Goldstein, Tony Romm and your Health 202 host report this morning. All these last-minute negotiations over the package’s health provisions have pitted some of the party’s most powerful wings against each other.

Medicaid conundrum

Even before Manchin's concerns, Democrats’ original plan to permanently extend Medicaid coverage to those in non-expansion states seem unlikely to make it into the legislation, two people familiar with the negotiations told Dan and your host. This comes as lawmakers have been significantly trimming the size of what was once expected to be a $3.5 trillion package. 

  • In the meantime: Leaders are increasingly coalescing around a strategy that would let people in those states receive free plans in Obamacare’s online insurance marketplaces for four years, or until 2025.
  • Yet it’s unclear what will come of Manchin’s resistance. The Senate can’t afford any Democratic defections on Biden’s economic package and still pass the bill.
As for Medicare

Nor does Manchin like the Medicare benefits expansion, which was originally forecast to cost more than $350 billion. Yesterday, the senator renewed his concerns to reporters about spending money on new coverage before fixing the federal program's finances.

At a televised CNN town hall Thursday, Biden said it’d be a “reach” to expand Medicare to include dental, vision and hearing benefits, citing Manchin's opposition. Instead, Biden floated the idea of sending seniors an $800 voucher to get the dental work they need, though he emphasized Thursday: “I don’t have a deal on it yet.”

  • But that proposal is already facing pushback. Six health advocacy groups — such as the Center for Medicare Advocacy and Families USA — argued the idea was “not a replacement for real coverage” and predicted problems that “would minimize any expected political payoff.”
  • Vouchers have also been panned by an array of lawmakers, ranging from Manchin to liberal stalwart Rep. Debbie Dingell (D-Mich.), even as other members retrench to fight for their priorities.

Medicare expansion is a top priority for Sen. Bernie Sanders (I-Vt.), who previously called the inclusion of the benefits “not negotiable,” as well as for members of the Congressional Progressive Caucus. One member of the 96-member strong CPC predicted they’d ultimately follow Sanders’ lead. 

  • “Most of us on this issue will look to his leadership,” Rep. Ro Khanna (D-Calif.) told The Health 202. “Any compromise in it is his to make, but I certainly don’t think progressives would support a bill that he did not on this issue.”

Sen. Bernie Sanders (I-Vt.)


The White House says it doesn’t have “unlimited rights” to Moderna’s recipe

A legal review has found the administration does not have the authority to force Moderna to hand over its vaccine recipe, two administration officials told The Post’s Dan Diamond.

The review comes as public health experts and advocates have urged the Biden administration to share confidential details about Moderna’s vaccine recipe with other countries to expand production of the lifesaving vaccines.

Advocates cite the federal government’s role in developing technology behind the vaccine and the fact that Moderna has received $10 billion in federal dollars to expand its manufacturing. 

  • Some public health experts have also keyed in on a provision in Moderna’s contract that specifies that the federal government has “unlimited rights” to data funded under the contract. But one White House official says that line has been taken out of context and is based on a redacted document.

FDA advisers meet today to discuss Pfizer’s vaccine for kids

Advisers will be asked to recommend a two-dose series of the Pfizer vaccine for kids ages 5 to 11, with each dose one-third that of what is given to adults.

Among the presentations: Matthew Oster, a pediatric cardiologist and a medical officer at the Centers for Disease Control and Prevention, will discuss the risk of heart inflammation in adolescents and young adults linked to the vaccine. The FDA’s Hong Yang will talk through a risk-benefit analysis for the shot.

The FDA’s position: The FDA’s briefing document ahead of the meeting appears to clear the way for a positive recommendation. The agency found that for four different scenarios of the pandemic, the benefits outweigh the risks.

  • In only one scenario, where coronavirus transmission was at its lowest level, did the agency’s models estimate that more kids could be hospitalized because of heart inflammation linked to the vaccine than would be kept out of the hospital due to the shots’ protection from covid-19.
  • Even in that scenario, however, kids could still be safer getting the shot, given that most cases of heart inflammation linked to the vaccine have cleared up quickly, whereas kids who are hospitalized for covid-19 may be at higher risk.

Key background: Children are generally at less risk of severe disease than adults. But pediatricians also point out that the vaccine can help protect kids’ parents and caregivers.

Meanwhile: Moderna is playing catch-up. The company released interim data Monday, however, showing that its vaccine provokes a strong immune response in kids ages 6 to 11.

The Biden administration wants to speed up authorization of rapid covid tests

The National Institutes of Health will leverage $70 million as part of a program to help manufacturers navigate the regulatory process, The Post’s Yasmeen Abutaleb reports. The program, which relies on money from the American Rescue Plan passed earlier this year, will also identify rapid tests that could be produced and distributed at mass scale.

The at-home tests could be particularly valuable in distinguishing between the flu and the coronavirus as America enters flu season. They could also play a crucial role in workplace testing as the Biden administration finalizes a rule that will require all unvaccinated workers at businesses with 100 or more employees to get weekly tests.

  • The announcement is part of a broader effort to expand at-home testing in the U.S., which has lagged behind other countries in terms of the affordability of rapid tests and the number of tests available. While rapid tests are somewhat less accurate than lab-based PCR tests (around 80 percent sensitive compared with 98 percent), they can deliver results in real-time and be administered regularly.

Meanwhile, some federal advisers have booster misgivings

Advisers to the FDA and CDC have overwhelmingly — and in some cases unanimously — voted to support coronavirus booster shots for tens of millions of Americans. But those votes may obscure significant discontent among advisers, The New York Times’s Apoorva Mandavilli reports. 

  • “All the advisers acknowledged that they were obligated to make difficult choices, based on sparse research, in the middle of a public health emergency. But some said they felt compelled to vote for the shots because of the way the federal agencies framed the questions that they were asked to consider,” Apoorva writes.
  • Some advisers told Apoorva that they felt they had little choice but to vote in favor of boosters for Moderna and Johnson & Johnson after recommending additional shots for the Pfizer vaccine.

Industry Rx

Theodoric Meyer shares with us more details on jockeying over the drug bill: Pharmaceutical Research and Manufacturers of America, the pharmaceutical industry's powerful trade group, has said it supports efforts to lower prescription drug prices, we reported Monday. It just opposes Democrats' current plans to do so, which it argues would cost jobs and hinder the discovery of new drugs, he writes.

But the trade group hasn't rushed to put out a counter-proposal. Stephen Ubl, PhRMA's president and chief executive, pledged on Sept. 1 to share details the trade group's own plan to bring down prescription drug prices with the Biden administration in a meeting with Susan Rice, the head of the White House's Domestic Policy Council, and pharmaceutical company executives, a person familiar with the matter told Theo.

Nearly two months later, though, the White House hasn't received any such proposal, according to the person.

  • A PhRMA spokesperson declined to comment beyond PhRMA's previous statement that it's had “constructive engagement with policymakers" on lowering "costs for patients, while protecting choice, access and future innovation.

Sugar rush

Thanks for reading! See y'all tomorrow.